May 10th, 2021 Bigfoot Biomedical The Food and Drug Administration has rubber-stamped a smart cap system for insulin pens. Bigfoot Unity works with an integrated continuous glucose monitoring system (iCGM) to provide recommendations for insulin doses. According to Bigfoot Biomedical, it's the "only FDA-cleared dose decision support system with real-time hypoglycemia alerts" and it can help patients minimize the guesswork for how much insulin they need. For now, Bigfoot Unity only supports Abbott's FreeStyle Libre 2, one of the two major iCGMs alongside Dexcom. It's designed for people with Type 1 or Type 2 diabetes who are using multiple daily injection (MDI) therapy. The connected smart cap displays the recommended dose, along with the patient's glucose value and trend arrow, without them having to manually enter their blood sugar data on a separate device.